(156 days)
OLYMPUS OTV-S300: This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A, WA50082A: This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs. The device is also indicated for visualization during transanal and transvaginal natural orifice surgery.
The subject VISERA ELITE II consists of the following primary components:
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300
- VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A/ WA50082A
A) VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTY-S300: The subject device has both a processor function and light source function. By switching on the illumination lamp in the subject device provides light through the endoscopes directly for endoscopic observation. This device also constantly regulates the endoscopic image brightness from the video system center. The observation mode can be switched by the optical filter and LED extracting the specific wavelengths. There are two modes: WLI (White light imaging) mode for normal observation and NBI (Narrow-band imaging) mode for an optical image enhancement technology. By driving the CCD equipped in the endoscopes, the images are transduced into electrical signals from the optical signals, and the subject device displays the endoscopic images on the monitors.
B) VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3DWA50080A/ WA50082A: The subject devices are designed to transfer optical images from a body cavity via a lens system directly to an imager for further electrical signal transmission to a video processor. The video telescope is designed for examination, diagnosis, and visualization of treatment (treatment can only be performed by using endoscopic accessories in combination). For illumination of body cavities, the transfer of light from a supply unit to the body cavity is achieved by means of a light guide. The subject device, ENDOEYE 3D, is a design variant of the predicate ENDOEYE HD II video endoscope offering a 3D observation mode. The 3D effect enables the surgeon to perceive significant spatial information which is beneficial in terms of optimized speed, accuracy and precision of surgical procedures by users of all skill levels. It may also shorten the learning curve for surgical tasks. The ENDOEYE 3D is used with a 3D video system and a 3D monitor with dedicated polarization glasses. For laparoscopic applications, the video telescope is inserted via a trocar into the patient. The ENDOEYE 3D is used with a video system center, light source and monitor to achieve its intended function. In addition, the ENDOEYE 3D can be placed in compatible instrument trays for reprocessing. The ENDOEYE 3D can provide an image with either white light or narrow band imaging.
This document is a 510(k) summary for the Olympus VISERA ELITE II VIDEO SYSTEM CENTER OTV-S300 and VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A, WA50082A. It describes various performance data gathered to support the substantial equivalence determination but does not include an AI algorithm. Therefore, many of the requested fields are not applicable (N/A) or not provided in the document.
Acceptance Criteria and Device Performance for Non-AI Devices
For the Olympus VISERA ELITE II Video System Center and Video Telescope, the acceptance criteria are based on compliance with established in-house criteria derived from international and FDA guidelines, as well as satisfactory performance in bench testing and other validations. Since this is not an AI device, there are no reported performance metrics like accuracy, sensitivity, or specificity in the conventional sense of an AI study. Instead, performance is demonstrated through successful completion of various engineering and functional tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|---|
| Risk Analysis | In accordance with established in-house acceptance criteria based on ISO 14971:2007. | Design verification tests and acceptance criteria were identified and performed as a result of the risk analysis assessment and successfully completed. |
| Reprocessing Validation | In accordance with FDA Guidance for Industry and Staff: "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling". | Documentation provided, indicating successful validation. |
| Biocompatibility Testing | In accordance with FDA's Guidance for Industry and Staff: "Use of International Standard ISO 10993-1". | Successfully conducted tests for in vitro cytotoxicity, irritation, acute systemic toxicity, material-mediated pyrogenicity, and dermal sensitization. |
| Software V&V | In accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". | Documentation provided, indicating successful verification and validation. |
| Electrical Safety & EMC | Compliance with ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, IEC 60601-2-18:2009 for safety, and IEC 60601-1-2:2014 for EMC. | System complies with the specified standards. |
| Bench Testing (OTV-S300) | Design specifications for: Emergency Lamp Function, NBI Observation, General Observation Function, Image Quality (Brightness, Image Intensity, Color Performance, Signal to Noise ratio), Usability. | Tests conducted to ensure the device performs as intended and meets design specifications. (Specific results not detailed, but implied successful completion). |
| Bench Testing (WA50080A/ WA50082A) | Design specifications for: Real-use contamination, Field of View, Design Validation/Usability, Optical properties (pred vs. subject), Thermal Safety, Surfaces and Edges, Working Length, Ghost effect, Still image, Distortion, Resolution, Performance after reprocessing, Illumination performance, Mechanical stress resistance. | Tests conducted to ensure the device performs as intended and meets design specifications. (Specific results not detailed, but implied successful completion). |
| Bench Testing (Both) | Design specifications for Photobiological safety. | Tests conducted to ensure the device performs as intended and meets design specifications. (Specific results not detailed, but implied successful completion). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests. The tests refer to the devices themselves (OTV-S300 and WA50080A/WA50082A). The "test set" in this context refers to the manufactured devices undergoing various bench and validation tests.
- Data Provenance: The studies are internal performance validation tests conducted by Olympus, a manufacturer based in Japan and Germany, likely representing prospective testing of the devices to meet regulatory requirements prior to market entry.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable (N/A): This is not an AI device that requires expert-established ground truth for its performance evaluation in the context of diagnostic accuracy. The assessments are based on engineering specifications and adherence to standards.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): No adjudication method is described as this is not a study assessing human or AI diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
- Not Applicable (N/A): No AI is involved, and therefore no MRMC study or AI-assisted human performance evaluation was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable (N/A): No AI algorithm is part of this submission, so no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- Not Applicable (N/A) in the AI context: For this medical device, "ground truth" is established by engineering specifications, validated test methods, adherence to international standards (e.g., ISO, IEC), and functional requirements for safe and effective endoscopic imaging. It's about meeting designed-in performance parameters, not an external diagnostic reference.
8. The Sample Size for the Training Set
- Not Applicable (N/A): There is no AI algorithm, so no training set for an algorithm is involved.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A): No AI algorithm or training set is present.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.